Volume 146, Issue 7, Pages 1649-1658 (June 2014) Glutenase ALV003 Attenuates Gluten-Induced Mucosal Injury in Patients With Celiac Disease  Marja-Leena Lähdeaho, Katri Kaukinen, Kaija Laurila, Pekka Vuotikka, Olli-Pekka Koivurova, Tiina Kärjä-Lahdensuu, Annette Marcantonio, Daniel C. Adelman, Markku Mäki  Gastroenterology  Volume 146, Issue 7, Pages 1649-1658 (June 2014) DOI: 10.1053/j.gastro.2014.02.031 Copyright © 2014 AGA Institute Terms and Conditions

Figure 1 Therapeutic intervention study schema. Patients were randomized to receive ALV003 or a placebo drug. All patients ingested 2 g gluten daily for 6 weeks. Upper gastrointestinal endoscopy with duodenal mucosal biopsies was performed at day 0 (baseline) and at post treatment. F/U, follow up. Gastroenterology 2014 146, 1649-1658DOI: (10.1053/j.gastro.2014.02.031) Copyright © 2014 AGA Institute Terms and Conditions

Figure 2 Gluten-dose optimization. (A) Mean (±SE) VH:CrD at baseline and end of the 6-week gluten challenge in patients on long-term GFD. (B) Six-week gluten challenge dose−response effect trend on VH:CrD (mean ± SE). Gastroenterology 2014 146, 1649-1658DOI: (10.1053/j.gastro.2014.02.031) Copyright © 2014 AGA Institute Terms and Conditions

Figure 3 Distribution of patients in the therapeutic intervention study. ITT, intention to treat; TG2-IgA, transglutaminase 2 IgA class antibodies. Gastroenterology 2014 146, 1649-1658DOI: (10.1053/j.gastro.2014.02.031) Copyright © 2014 AGA Institute Terms and Conditions

Figure 4 Duodenal mucosal biopsy morphometric data points (mean ± SE): (A) VH:CrD, (B) CD3+ IEL, (C) αβ and (D) γδ densities (cells/mm epithelium) in celiac disease patients on a long-term GFD at the baseline and after 6-week gluten challenge (2g/day). Gastroenterology 2014 146, 1649-1658DOI: (10.1053/j.gastro.2014.02.031) Copyright © 2014 AGA Institute Terms and Conditions